Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

EBG 2020-09-09

Structur CAD

Applicant Voco GmbH

K-Number K201090

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NEW 2020-09-09

MINT Product Family

Applicant Hans Biomed Corporation

K-Number K192423

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FXX 2020-09-08

Surgical Mask-Model Number CW01

Applicant Hunan Heng Chang Pharmaceutical Co., Ltd.

K-Number K202354

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LNH 2020-09-08

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K202014

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FXX 2020-09-08

Disposable Medical Face Mask

Applicant Jkh USA, LLC

K-Number K201470

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NKB 2020-09-08

CD Horizon Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K202328

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DQY 2020-09-08

ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),

Applicant Asahi Intecc Co., Ltd.

K-Number K202252

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HQD 2020-09-08

Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K201194

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QEA 2020-09-06

EyeBOX

Applicant Oculogica, Inc.

K-Number K201841

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DWJ 2020-09-04

Astopad Patient Warming System

Applicant Stihler Electronic GmbH

K-Number K202197

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QEH 2020-09-04

BD Syringe NRFit Lok and BD Syringe NRFit Slip

Applicant Becton, Dickinson and Company

K-Number K192538

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DZE 2020-09-04

Neodent Implant System - GM Helix Implants 7.0

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K201225

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